Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Receipt is acknowledged of Applicant’s Amendment filed on 07/08/2026; and IDS filed on 07/08/2026.
Claims 1, 13-15 have been amended.
Claims 3, 9-12 have been canceled.
Claims 1-2, 4-8, 13-21 are pending in the instant application.
Claims 13-21 are withdrawn from consideration.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/010,219 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-application recites a core-shell microparticle having an average diameter of up to 10 µm, wherein the microparticle comprises a biodegradable polymer and has at least two or more surface cavities which comprise surface indentations having an average diameter of from 0.4 to 1.0 µm, wherein the surface cavities are capable of trapping a gas bubble at the surface of the particle, and wherein the shell further comprises one or more drugs, wherein the one or more drugs are selected from the group consisting of anti-inflammatory drugs, immunosuppressants, anti- proliferative drugs, anti-coagulants, and combinations thereof (see amended claim 1 filed on 04/16/2026).
The difference between instant application and the patented claims is that the patent claims include additional limitations. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 6, 8 are is/are rejected under 35 U.S.C. 103 as being unpatentable over SEEKELL et al (Oxygen delivery using engineered microparticles. Proc Natl Acad Sci USA . 2016 Nov 1;113(44):12380-1238).
SEEKELL teaches polymer hollow microparticles (see abstract), which has a core-shell geometry (see pg. 12381, 1st col), for oxygen delivery (see title) comprised of: poly(D,L-lactic-coglycolic) acid polymers (“PLGA”; see pg. 12381, 1st col), where the mean diameters in the examples are 8.5 um 9.3 um (see pg. 12381, 2nd col) and mean pore/cavity diameters are 0.24 and 1.4 um (see pg. 12381, 2nd col). Additional disclosures include: particle size and pore/cavity diameter by controlling homogenization speed and precipitation rate of the PLGA (see pg. 12381, 2nd col).
The reference does not specifically teach the surface cavities/pores average diameter in the range of 0.4 to 1.0 um as claimed by Applicant, because SEEKELL teaches a broader range of 0.24 to 1.4um. The surface cavities/pores average diameter range in a porous microparticle composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal surface cavity/pore size in order to best achieve the desired results, such as the rate of oxygen delivery through the pores/cavities. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of surface cavity/pore average diameter range would have been obvious at the time of Applicant's invention.
Note, the prior art’s composition would be capable of being used as an ultrasound contrast agent, because the prior art’s composition has the same ingredients as claimed by Applicant. Especially, when PLGA are well-known to be ultrasound detectable.
Claim(s) 1-2, 6-8 are is/are rejected under 35 U.S.C. 103 as being unpatentable over KIM et al (Biodegradable Microparticles with Surface Dimples as a Bi-Modal Imaging Contrast Agent. Macromol. Rapid Commun. 2013, 34, 406−410) as evidence/in view of KIM et al (Golf ball-shaped PLGA microparticles with internal pores fabricated by simple O/W emulsion. Chem. Commun., 2010, 46, 7433–7435; wherein after “KIM2).
KIM teaches sub-10-um-sized PLGA microparticles with small dimples (see abstract) encapsulating Rhodamine 6G (see pg. 407, 1st col.), which reads on a hydrophobic chemical, and iron oxide (see pg. 407, 1st col), which reads on hydrophilic drug, wherein an SEA image of the microparticle with dimples from Figure 2(d) is provided below (see below; and pg. 408, Figure 2(d)):
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KIM’s dimples read on surface cavities and appear to have the average diameter within Applicant’s range of 0.4 to 1um (see Figure 2(d) as shown above). KIM further teaches the size of the dimples can be reduced/adjusted by using 2-methypentane or use of other surfactants (see pg. 408, under 3. Result and Discussion). The small particles are appealing for cell-tracking and imaging applications (see pg. 406, 2nd col), wherein the microstructures can be used as biomedical imaging contrast agent (see pg. 409, 1st col).
KIM2 is the same inventor and teaches dimpled PLGA microparticles can be used as a carrier for active agents (see pg. 407, 1st col), such as a hydrophobic chemical agent (Rhodamine 6G; see pg. 7433, 2nd col) and/or hydrophilic silica colloid (see pg. 7433, 2nd col). Thus, it would have been obvious to incorporate hydrophilic or hydrophobic drugs/chemicals. KIM2 further teaches “dimpled surface combined with complex internal porous morphology, advantages of increased surface area for drug release, providing additional loading sites on the particle surface which can be used as enhanced biomolecular imaging systems4 and multiple drug dosing systems, and potential for modified interaction with biological systems can be expected. As a golf ball with dimple structures on the surface can prolong the distance of flight by reducing the drag force by air, mimicking its structure in microparticles is also expected to reduce the drag force exerted on the microparticles when it is necessary to move in the fluid (see pg. 7433, 1st col).
The references do not specifically teach the particle average diameter of 5 to 6 um or surface cavities/dimples having an average diameter of 0.4 to 1.0 um as claimed by Applicant. The particle size and surface cavities/dimples size in a dimpled microparticle composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal the particle size and surface cavity/dimple size in order to best achieve the desired results, such size need for different biomedical applications, drug release rate, imaging, etc. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of particle size and cavity/dimple size would have been obvious at the time of Applicant's invention.
Note, the prior art’s composition would be capable of being used as an ultrasound contrast agent, because the prior art’s composition has the same ingredients as claimed by Applicant. Especially, when PLGA are well-known to be ultrasound detectable.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAKE M VU/Primary Examiner, Art Unit 1618
